Fludarabine phosphate - Generic Drug Details
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What are the generic drug sources for fludarabine phosphate and what is the scope of patent protection?
Fludarabine phosphate
is the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Rising, Sagent Pharms Inc, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for fludarabine phosphate. Five suppliers are listed for this compound.
Summary for fludarabine phosphate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 11 |
| NDAs: | 13 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 484 |
| Patent Applications: | 4,763 |
| What excipients (inactive ingredients) are in fludarabine phosphate? | fludarabine phosphate excipients list |
| DailyMed Link: | fludarabine phosphate at DailyMed |
Recent Clinical Trials for fludarabine phosphate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fred Hutchinson Cancer Center | Phase 2 |
| National Cord Blood Network | Phase 2 |
| University Cancer Research Fund at Lineberger Comprehensive Cancer Center | Phase 1/Phase 2 |
Pharmacology for fludarabine phosphate
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for fludarabine phosphate
US Patents and Regulatory Information for fludarabine phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sagent Pharms Inc | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 076661-001 | Apr 28, 2004 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Areva Pharms | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724-001 | Sep 27, 2010 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 200647-001 | Dec 21, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 078544-001 | Oct 15, 2007 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Llc | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 203738-001 | Feb 28, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for fludarabine phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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